The FDA's drug center is launching a pilot program this month to evaluate whether disclosing certain information included in company-generated clinical study reports (CSRs) following a drug's approval would improve public access to the approval information.

The Senate Health, Education, Labor and Pensions (HELP) Committee began the process of reauthorizing the 2006 Pandemic and All-Hazards Preparedness Act (PAHPA) last week, which provides funding through this fiscal year for the research, development and national stockpile purchase of medical countermeasures (MCMs). In its first iteration, PAHPA led to the FDA approval of 34 MCMs that were supported by the Biomedical Advanced Research and Development Authority; 12 drugs were approved under the Animal Rule.

The FDA and the Department of Defense's (DoD) Office of Health Affairs launched a joint program to prioritize the development of medical products intended to save the lives of U.S. military personnel. Under the program, the FDA will work with Health Affairs to better understand the military's medical needs for deployed personnel, expedite its review of priority DoD medical products in a manner similar to its breakthrough designation program, provide ongoing technical advice to assist in the rapid development and manufacturing of medical products for use by the military, and take a closer look at products already under development to determine ways to expedite their availability. The two agencies plan to hold workshops this year to discuss aspects of the scientific and clinical development of products DoD needs.